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FDA 510(k)

POLARUS CAP SCREW

K-Number: K013616 · 2001-12-19

ApplicantAcu Med, Inc.
Decision Date2001-12-19
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

POLARUS CAP SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Acu Med, Inc.. It received FDA 510(k) clearance on 2001-12-19 under 510(k) number K013616. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLARUS CAP SCREW?

POLARUS CAP SCREW is a medical device that received FDA 510(k) clearance on 2001-12-19. The listed applicant is Acu Med, Inc.. The 510(k) number is K013616.

When did POLARUS CAP SCREW receive FDA 510(k) clearance?

POLARUS CAP SCREW received FDA 510(k) clearance on 2001-12-19, under 510(k) number K013616.

Who is the listed applicant for POLARUS CAP SCREW?

The FDA 510(k) record lists Acu Med, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLARUS CAP SCREW?

The FDA product code for POLARUS CAP SCREW is HSB.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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